FDA.reportPublic FDA data

Levofloxacin

Product NDC
25021-132
11-digit product format
250210132
Labeler code
25021
Product ID
25021-132_364ea810-a100-4a99-9a82-144a30e96572
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Levofloxacin
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Sagent Pharmaceuticals
Application
ANDA090343
Marketing category
ANDA
Marketing start
2011-06-20
Substance
LEVOFLOXACIN
Active strength
5 mg/mL
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Levofloxacin
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LEVOFLOXACIN5 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii6GNT3Y5LMF
Rxcui1665497, 1665507, 1665515

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
addb5519-f7ae-4d4e-b9ca-f782a1597fd3Product name220210610
fb758c6a-fdee-40a8-99c2-46f79c3ff90cProduct name420200807
1a81e9a9-11c3-4fcf-b5dd-f6798fef8e6dProduct name120190618
aea4a616-4dfe-45f6-94bb-8b9063056cebProduct name620190611
2246ce8e-a477-4dc3-b6d6-fe9973c18ed1Product name120180821
5a6c788d-375b-4565-a8ae-67c179a30c93Product name120180212

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
25021-132-81Levofloxacin24 in 1 CARTONINJECTION, SOLUTION2421
25021-132-81Levofloxacin1 in 1 POUCHINJECTION, SOLUTION121
25021-132-82Levofloxacin24 in 1 CARTONINJECTION, SOLUTION2421
25021-132-82Levofloxacin1 in 1 POUCHINJECTION, SOLUTION121
25021-132-83Levofloxacin24 in 1 CARTONINJECTION, SOLUTION2421
25021-132-83Levofloxacin1 in 1 POUCHINJECTION, SOLUTION121

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
25021-132-67ML - Milliliter25021-1324d536408-f03b-4ddb-9cf2-137d590396c912013-09-04
25021-132-68ML - Milliliter25021-132a643e617-aa90-4ea0-8c6f-fbbe9e6cedbd12013-09-04
25021-132-81ML - Milliliter25021-13291dc9ef1-5f0c-4ab0-901c-39d8ece5a19a12012-07-24
25021-132-82ML - Milliliter25021-132725f4471-ad3a-4a3d-9641-a9f83b2de3f112012-07-24
25021-132-83ML - Milliliter25021-132254468b4-7155-494c-82e8-e32a907db64612012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
levofloxacinACTIVE INGREDIENT6GNT3Y5LMFLEVOFLOXACIN INJECTION, SOLUTION [SAGENT PHARMACEUTICALS]12
Levofloxacin AnhydrousACTIVE MOIETYRIX4E89Y14LEVOFLOXACIN INJECTION, SOLUTION [SAGENT PHARMACEUTICALS]12
dextroseINACTIVE INGREDIENTIY9XDZ35W2LEVOFLOXACIN INJECTION, SOLUTION [SAGENT PHARMACEUTICALS]12
hydrochloric acidINACTIVE INGREDIENTQTT17582CBLEVOFLOXACIN INJECTION, SOLUTION [SAGENT PHARMACEUTICALS]12
sodium hydroxideINACTIVE INGREDIENT55X04QC32ILEVOFLOXACIN INJECTION, SOLUTION [SAGENT PHARMACEUTICALS]12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
25021-132LEVOFLOXACIN INJECTION, SOLUTION [SAGENT PHARMACEUTICALS]21Current NDC, Legacy NDC, 6 package rows20241206_699fbdb8-a6fd-476a-9b80-08197d869534.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1665497levoFLOXacin 250 MG in 50 ML InjectionPSN699fbdb8-a6fd-476a-9b80-08197d86953421
1665507levoFLOXacin 500 MG in 100 ML InjectionPSN699fbdb8-a6fd-476a-9b80-08197d86953421
1665515levoFLOXacin 750 MG in 150 ML InjectionPSN699fbdb8-a6fd-476a-9b80-08197d86953421
1665507100 ML levofloxacin 5 MG/ML InjectionSCD699fbdb8-a6fd-476a-9b80-08197d86953421
1665515150 ML levofloxacin 5 MG/ML InjectionSCD699fbdb8-a6fd-476a-9b80-08197d86953421
166549750 ML levofloxacin 5 MG/ML InjectionSCD699fbdb8-a6fd-476a-9b80-08197d86953421
1665497levofloxacin 250 MG per 50 ML InjectionSY699fbdb8-a6fd-476a-9b80-08197d86953421
1665507levofloxacin 500 MG per 100 ML InjectionSY699fbdb8-a6fd-476a-9b80-08197d86953421
1665515levofloxacin 750 MG per 150 ML InjectionSY699fbdb8-a6fd-476a-9b80-08197d86953421

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
25021-132-812502101328124 POUCH in 1 CARTON (25021-132-81) / 1 BAG in 1 POUCH / 50 mL in 1 BAG24 pouch2011-06-200000-00-00NoNoCurrent
25021-132-822502101328224 POUCH in 1 CARTON (25021-132-82) / 1 BAG in 1 POUCH / 100 mL in 1 BAG24 pouch2011-06-200000-00-00NoNoCurrent
25021-132-832502101328324 POUCH in 1 CARTON (25021-132-83) / 1 BAG in 1 POUCH / 150 mL in 1 BAG24 pouch2011-06-200000-00-00NoNoCurrent